The following invention relates generally to instrumentalities and methodologies in preparing and administering biological adhesives. More specifically, the instant invention is directed to a method and apparatus for simultaneously loading dispensing assemblies with multiple components of biological glue and preparing the biological glue in a manner specific to the required need.
This application represents applicant""s ongoing efforts in the field of collecting, preparing, and dispensing components of biological adhesives.
U.S. Pat. No. 5,759,171 discloses a sprayer for fibrin glue configured with a pistol grip, barrel, and trigger, and adapted to hold two syringes containing the fibrin glue components. Activation of the trigger moves a plunger support, emptying the two syringes. Each syringe communicates with an outlet having an atomizer, and the atomizers are oriented to form the fibrin glue away from the tip of the sprayer, to prevent clogging.
U.S. Pat. No. 5,975,367 is directed to a hand-held dispenser for fibrin glue. The dispenser includes a spring-based rack that communicates with two syringes containing fibrin glue components such that the dispensed components may mix away from the tip of the dispenser. Drops or elongate lines of fibrin glue may be dispensed.
U.S. Pat. No. 6,077,447 reveals an apparatus, system and method for fractionating from whole blood, plasma, or other blood products the clotting factor known as fibrinogen, one component of a biological adhesive. A container is loaded with blood product containing fibrinogen, and the container is then put in registry with a heat transfer platen. The platen and container combination is rocked contemporaneously with temperature changes that induce a phase change in the blood product. The fibrinogen is then extracted from the container for subsequent use.
U.S. Pat. No. 6,274,090 B1 divulges an apparatus and method for preparing thrombin, another component of a biological adhesive. The thrombin component is extracted from donor plasma and converted to thrombin, while also removing contaminating proteins. Additionally, a system is described in which thrombin and adhesive and clotting proteins are simultaneously harvested from the same donor plasma, providing a more stable product than previously available. Both procedures occur in about one hour in a sterile environment, and are thereby optimized for use in a surgical setting.
WIPO application 00/74713A1 describes an improved thrombin processing unit that may be used with the methods revealed in U.S. Pat. No. 6,274,090 B1.
The present invention streamlines processing of thrombin and adhesive and clotting proteins to produce biological adhesives. Processing time is shorted, and the loading of syringes with the biological adhesives may be accomplished with improved sterility, less waste and more expeditious and particularly safer handling (e.g., from needle sticks) than heretofore experienced.
The present invention especially enhances the economics and practicalities of processing blood into biological adhesives. Customarily, a donor provides 500 mL (one xe2x80x9cunitxe2x80x9d) of whole blood. This unit, when processed, yields 250-300 mL of plasma, which results in two components: 4.5-8.5 mL clotting proteins and about 8.5 mL of thrombin. Since the minimum quantum of biological adhesive needed comprises 1-2 mL, and because each component comprises approximately 50 percent of the two-part adhesive, one unit of whole blood can generate approximately 4 to 8 doses of biological adhesive. The instant invention loads and packages biological adhesive in convenient doses.
Syringe pair assemblies are attached to a dispensing manifold on a loading station. Processing units for each component of the biological adhesive are mounted near the dispensing manifold, with dispensing lines running therebetween. Blood product is introduced into the separate processing units for the components for the adhesive. The desired component is extracted from the blood product. The components run through separate dispensing lines into syringes such that each syringe pair contains one syringe loaded with each component. The syringe pairs are removed from the dispensing manifold, and may be utilized in a variety of ways when in actual use. The syringes are compatible with an adhesive spraying apparatus, and may also be used with a heating station to maintain the adhesive components at an optimal temperature for use in a surgical setting.
Accordingly, it is a primary object of the present invention to provide a new and novel device and method for loading multiple syringes with biological glue components.
It is a further object of the present invention to provide a device and method as characterized above in which the loading procedure is independent of the application for which the biological glue is utilized.
It is a further object of the present invention to provide a device and method as characterized above which minimizes waste in loading the biological glue dispenser, improves efficiency and maintains sterility.
It is a further object of the present invention to provide a device and method as characterized above that minimizes clogging of the dispenser in delivering the biological glue to the intended site.
It is a further object of the present invention to provide a device and method as characterized above that may be utilized in a surgical setting.
Viewed from a first vantage point, it is an object of the present invention to provide an apparatus for collecting thrombin and clotting proteins, comprising, in combination: a first conduit operatively connected to a source of thrombin; and a second conduit operatively connected to a source of clotting proteins, each said conduit operatively connected to a plurality of dispensing means.
Viewed from a second vantage point, it is an object of the present invention to provide a method for loading dispensing means with thrombin and clotting proteins, the steps including: attaching a plurality of said dispensing means to separate dispensing lines containing thrombin and clotting proteins; manipulating said plurality of dispensing means to purge air in each of said dispensing lines; and sequentially filling said plurality of dispensing means through each of said dispensing lines.